This is a randomized, controlled, open-label, single-center study comparing the effects of efavirenz (EFV) versus rilpivirine (RPV) on endothelial function in a total of 40 HIV-uninfected healthy volunteers (20 in each arm) at the Indiana University Medical Center. Enrolled subjects will have their brachial artery flow-mediated dilation (FMD), a measure of endothelial function, and other cardiovascular, inflammatory, and oxidative stress parameters measured at baseline and again after 4 weeks of study treatment.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

18 years of age or older

Negative ELISA for HIV-1 or HIV-2 at screening

Negative hepatitis B surface antigen at screening

Negative hepatitis C antibody at screening

For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study

For men who are capable of impregnating a female sexual partner, a willingness to use condoms with spermicidal gel for all sexual contacts during the course of the study

No documented history of or receipt of medications being used to treat any psychiatric disorder, including (but not limited to) depression, dysthymia, mania, bipolar disease, schizophrenia, or previous suicidal ideation/attempts

No anticipated changes or additions to other medical therapies during the course of the study

Hypotension, defined as SBP < 90mmHg at time of each main study visit before brachial artery ultrasound measurements

Hypertension, defined as SBP > 160mmHg at time of screening

Receipt of investigational agents within 30 days of each screening visit or anticipated use during the trial

Receipt of cytotoxic chemotherapy within 30 days of each screening visit or anticipated use during the trial

Receipt of systemic glucocorticoids (> 10mg/day of prednisone or the equivalent), inhaled/nasal/topical fluticasone, or anabolic steroids within 30 days of each screening visit or anticipated use during the trial

Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing

Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing

Active drug or alcohol use or dependence that, in the opinion of the investigator or study personnel, would interfere with adherence to study requirements

Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit

History of migraine headaches

History of Raynaud's phenomenon

History of cardiac arrythmias

History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)

History of carotid bruits

History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within 45 days of screening

Use of antacids, H2-blockers, or proton pump inhibitors within 30 days of screening or anticipated use of these drugs during the trial

Any history of injection or illicit drug use

Presence of fever, defined as an oral or tympanic temperature > 100.3F, at either the Entry or Closeout Visits

On the PHQ-9 depression questionnaire at screening, a total score of more than 9 or any score over 0 on question 9.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585038